BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FREEDOM LITE

    MDR report key: 2073337 · Received May 1, 2011

    Report

    Report Number
    2954323-2011-03104
    Event Type
    Injury
    Date Received
    May 1, 2011
    Date of Event
    March 28, 2011
    Report Date
    June 22, 2011
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. THE PRODUCT HAS BEEN REQUESTED BACK FOR INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED. IT SHOULD BE NOTED THAT THE READING RELATED TO THE MEDICAL INCIDENT IS UNKNOWN. IN ADDITION, SELF-TREATMENT WITH INSULIN FOR A "LOW READING" IS INAPPROPRIATE AND ALSO REPORTED THIRD-PARTY MEDICAL INTERVENTION IS INCONSISTENT WITH THE DIAGNOSIS. ADC HAS MADE SEVERAL ATTEMPTS TO CONTACT THE CUSTOMER TO CLARIFY THIS INFORMATION WITHOUT SUCCESS. NOTE: THE DEVICE MANUFACTURE DATE IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    AS PRODUCT WAS NOT RETURNED AND TEST STRIP LOT REPORTED WITH THIS COMPLAINT IS EXPIRED, A DEVICE HISTORY REVIEW (DHR) OF THE TEST STRIPS WAS REQUESTED. THE DHR FOR LOT NUMBER 0877301 INDICATED THE TEST STRIPS WERE PERFORMING WITHIN THEIR PERFORMANCE CLAIMS AND MET THE MANUFACTURER'S QUALITY SPECIFICATIONS PRIOR TO THEIR RELEASE. THIS IS A FINAL REPORT.

    Description of Event or Problem · 1

    A CUSTOMER'S FAMILY MEMBER REPORTED CUSTOMER GOT A LOWER THAN FEELS READING OF 83 MG/DL ON THEIR FREESTYLE FREEDOM LITE METER AT 2:43PM ON (B)(6) 2010 AND ALSO INDICATED THE METER HAD THE WRONG DATE AND TIME IN IT. THE CALLER FURTHER REPORTED THE CUSTOMER WENT TO THE HOSPITAL ON THE (B)(6) 2011 AT 9PM AS A RESULT OF TAKING "INSULIN TO TREAT LOW READING AND THE READING WAS FALSELY LOW. " THE CUSTOMER REPORTEDLY EXPERIENCED VERTIGO AND "ALMOST PASSED OUT." THE PARAMEDICS WERE CALLED, INITIATED AN INTRAVENOUS INFUSION OF UNKNOWN TYPE AND TRANSPORTED HER TO A LOCAL HOSPITAL WHERE CUSTOMER WAS DIAGNOSED WITH HYPOGLYCEMIA AND GIVEN AN IV AND INSULIN SHOTS. IN ADDITION, CUSTOMER REPORTEDLY SELF-TREATED WITH METFORMIN WITH WATER IN ATTEMPT TO COUNTERACT THE EVENT. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS MEDICAL EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE FREEDOM LITE BLOOD GLUCOSE MONITORING SYSTEM NBW 0877301

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention